FDA.reportPublic FDA data

MAUDE MDR 9907997

MDR report key
9907997
Report number
3004753838-2020-31023
Event key
0
Event type
3
Date of event
2020-03-08
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS ASHLEY SPOTO
Address
6340 SEQUENCE DR. SAN DIEGO CA 92121 US
Phone
858-858-8582
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEMCONTINUOUS GLUCOSE MONITORDEXCOM, INC.QBJ9445-02STT-OE-0025265891R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.